Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Uterine Cervical Neoplasms

Pain

Pelvic Pain

Chronic Graft Versus Host Disease

* Patients will have a pelvic floor muscle exam performed by their gynecologic radiation oncologist prior to treatment, at treatment mid-point (after 3 weeks of treatment), at the end of treatment (after 6 weeks of treatment), and at a follow-up visit 6 months after the end of treatment. Patients will also complete the Pelvic Floor Impact Questionnaire 7 (PFIQ-7), Pelvic Floor Disability Index (PFDI-20), and the EORTC QLQ-CX24 at these time points.
* The patient will also undergo a standard of care MRI prior to starting treatment.

The exam takes approximately 5 minutes and uses a single digit to palpate the pelvic floor muscles, during which patients will rate pain on a scale of 0-10 at 5 paired locations.

Single digit pelvic exam

Tyler McKinnish, M.D.

Stephanie Markovina, M.D., Ph.D.

Julie Schwarz, M.D., Ph.D.

Premal Thaker, M.D.

The two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. The investigators hypothesize that an exam-based diagnostic tool will provide more information about the areas of injury related to pelvic radiation than patient-reported outcomes, and could be used in future studies of preventive strategies. An exam-based tool will also allow measurement of the pain dose-response to radiation treatment of specific areas, which could be excluded from radiation fields during treatment planning.

Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors

An exam will be considered positive for PFMD if pain at any examined site is reported as greater than or equal to four (\>4) out of 10. The EORTC QLQ-CX2 contains 24 items scored 1-4 by frequency with which the patient experiences each. The minimum possible score is 24, and maximum 96, with higher scores indicating worse quality of life. The questionnaire will be considered positive if any vaginal, sexual, or genitourinary module question is rated 4 and otherwise will be analyzed as a continuous variable.

An exam will be considered positive for PFMD if pain at any examined site is reported as \>4 out of 10. The PFDI-20 includes 20 items in three domains and provides a scaled score of 0-100 indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire will be considered positive if the scaled score is greater than or equal to 16, indicating at least "moderate distress" and otherwise will be analyzed as a continuous variable.

An exam will be considered positive for PFMD if pain at any examined site is reported as \>4 out of 10. The PFIQ-7 includes 7 items each repeated across three domains and provides a scaled score and total score indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire does not have an established severity scale, and therefore will be analyzed as a simple continuous variable.

Continuous variables of scales and total scores will be calculated for the exam at each time point and represented in spider-type plots. Results of the exam will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.

Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.

Continuous variables of scales and total scores, as well as specific scores for radiation-exposed structures on exam, will be compared to dosimetric assessments of exposure of pelvic floor structures.

Standard dosimetric values will be calculated for each specific pelvic floor structure evaluated on exam.

Historical controls will be queried via chart review for dosimetric values in archived radiation treatment plans and compared to current gynecologic radiation standards. These patients will also undergo thorough chart review for subsequent diagnoses of pelvic floor-related disorders and compared to the diagnosis rate using the proposed screening tools in this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors	NCT05769062	Gynecologic Can...	Single digit pe...	18 Years -	Washington University School of Medicine
Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors	NCT05769062	Gynecologic Can...	Single digit pe...	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for pelvic floor muscle dysfunction